combination chemotherapy plus radiation therapy in treating patients with non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. radiation therapy uses high-energy x-rays to damage tumor cells. combining chemotherapy and radiation therapy may kill more tumor cells. purpose: this phase i/ii trial is studying the side effects and best dose of radiation therapy when given with combination chemotherapy and to see how well they work in treating patients with non-small cell lung cancer that cannot be surgically removed.

objectives: * determine the maximum tolerated dose of radiotherapy in combination with carboplatin and paclitaxel in patients with unresectable non-small cell lung cancer. * determine the 2-year survival of patients treated with this regimen. * determine the progression-free local control rate in patients treated this regimen. * determine the tolerability of this regimen in these patients. * assess the quality of life of patients treated with this regimen. outline: this is a multicenter, dose-escalation study of radiotherapy. patients undergo radiotherapy\* once daily 5 days a week for 7 weeks and 2 days (a total of 37 fractions). patients concurrently receive paclitaxel iv over 3 hours and carboplatin iv over 30 minutes once weekly for 7 weeks. treatment continues in the absence of disease progression or unacceptable toxicity. note: \*no prophylactic nodal radiotherapy is administered cohorts of 3-6 patients receive escalating doses of radiotherapy until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. once the mtd is determined, 12 additional patients are treated at that dose level in the phase ii portion of the study. beginning 3 weeks after completion of radiotherapy, patients receive paclitaxel and carboplatin as above. treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. quality of life is assessed at baseline, once during the last week of radiotherapy, and then every 3 months for 2 years. patients are followed at 3 weeks, every 3 months for 21 months, and then every 6 months for 3 years. projected accrual: a total of 90 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed non-small cell lung cancer (nsclc) * stage i, ii, or iii nsclc that is unresectable due to tumor extent or other medical reasons * measurable disease * tumor must not exceed volume that would require radiation volumes greater than those allowed on this study * no more than blunting of the costophrenic angle on chest x-ray due to pleural effusions * no more than small effusions seen on chest ct scan only * no supraclavicular adenopathy patient characteristics: age: * 18 and over performance status: * ecog 0-1 life expectancy: * at least 12 weeks hematopoietic: * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * total bilirubin no greater than 1.5 times upper limit of normal (uln) or * direct bilirubin no greater than 1.5 times uln * ast no greater than 3 times uln renal: * creatinine clearance at least 40 ml/min cardiovascular: * no new york heart association class iii or iv heart disease pulmonary: * fev_1 at least 1 l or 35% of predicted other: * no grade 2 or greater peripheral neuropathy * no weight loss of 10% or more within the past 3 months * no uncontrolled infection * no other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinoma (carcinoma in situ), or localized prostate cancer * no other severe underlying disease that would preclude study participation * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic: * no prior biologic therapy for nsclc * no concurrent biologic therapy * no concurrent prophylactic filgrastim (g-csf) chemotherapy: * no prior chemotherapy for nsclc * no other concurrent chemotherapy endocrine therapy: * no prior endocrine therapy for nsclc radiotherapy: * no prior radiotherapy for nsclc surgery: * no prior surgery for nsclc

Keywords: stage i non-small cell lung cancer stage ii non-small cell lung cancer stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer